P0404Evolution of the IBD-Disability Index in a cohort of recently diagnosed CD patients: results from the prospective CROCO (Crohńs Disease Cohort) Study

Abstract Background Crohn’s disease (CD) often leads to progressive bowel damage and disability. Disability has been proposed as an endpoint for disease-modification trials despite lack of data on its evolution. We described the evolution of disability within the first two years in a cohort of newly diagnosed CD. Methods The Crohn’s Disease Cohort (CROCO) is an international, prospective, multicenter study (19 centers), in which enrollment is complete but follow-up is ongoing. It includes patients with newly diagnosed CD (within 12 months of diagnosis) and evaluates the progression of bowel damage and disability. Disability was measured using the validated Inflammatory Bowel Disease Disability Index (IBD-DI), which includes 14 questions scoring from 0-100 across domains of health, sleep and energy, emotional well-being, body image, pain, defecation, interpersonal activities, and work/education. The IBD-DI was categorized as no disability (0–20), mild disability (21–35), moderate disability (36–50), and severe disability (51–100). We assessed changes in IBD-DI scores between baseline and 24 months. Results Among the 539 patients enrolled in CROCO, the median time between diagnosis and inclusion was 3.7 1.5;7.3 months. IBD-DI was available at the time of inclusion in 517 patients (median IBD-DI=21.410.7-37.5). Distribution across IBD-DI categories is given in Table 1. At year 1 (multivariable analysis), female (OR = 2.08 1.17-3.69), patients with mild (OR = 5.232.52-10.86), moderate-to severe disease per Harvey-Bradshaw Index (HBI) (OR = 8.72 3.57-21.26 for) or with extra-intestinal manifestations (EIMs) (OR = 2.31 1.31-4.09) had higher IBD-DI. In 226 patients IBD-DI was available at baseline, year 1, and year 2 (Table 1). Between baseline and year 2, disability decreased in 31% of patients, remained stable in 48%, and increased in 21% (Figure 1). Changes in IBD-DI were significantly associated with sex (p = 0.003) and baseline symptoms (HBI) (p 0.001), but not with EIMs, treatments, or surgical history. Among patients who underwent intestinal resection within the first year after diagnosis, IBD-DI decreased in 33%, remained unchanged in 44%, and increased in 22% between baseline and year 2 (p = 0.92). Initiation of advanced therapy within the first year after diagnosis had no impact on changes in IBD-DI between baseline and year 2 (p = 0.63). Conclusion Disability in newly diagnosed CD patients remained highly dynamic in the first 2 years after diagnosis, with more than half of patients changing across categories, and a substantial proportion maintaining moderate-severe disability. These findings highlight a need for new strategies to better understand and promote disability improvement in early disease course. Conflict of interest: Prof. Dr. Buisson, Anthony: Consulting fees from: Abbvie, AlfaSigma, Amgen, Arena, Biogen, Celltrion, CTMA, Ferring, Galapagos, Guty Care, Janssen, Hikma, Lilly, Mylan, Nexbiome, Pfizer, Roche, Takeda, Tillotts Lecture fees from: Abbvie, AlfaSigma, Amgen, Biogen, Celltrion, Ferring, Galapagos, Hikma, Janssen, Lilly, Mayoli-Spindler, MSD, Pfizer, Roche, Sanofi-Aventis, Takeda, Tillotts, Vifor-Pharma Research fundings from: Abbvie, AlfaSigma, Celltrion, Janssen, Lessaffre, Lilly, Pfizer, Takeda Dodel, Marie: No conflict of interest Revés, Joana: None Arebi, Naila: Personal Fees: Janssen,Lilly, Pfizer and Takeda Non-financial Support: Janssen (J & J), Novonesis Fadra, Adam: None to declare Madsen, Gorm Roager: No conflict of interest Burisch, Johan: Grant: Johnson & Johnson, MSD, Takeda, Tillots Pharma, BMS, Novo Nordisk Personal Fees: Celgene, MSD, Pfizer, AbbVie, Takeda, Tillots Pharma, Samsung Bioepis, BMS, Pharmacosmos, Galapagos, Zealand Pharma, Orion Pharma, Ferring, Johnson & Johnson Cravo, Marilia: No conflict of interest Kaimakliotis, John: No conflict of interest Vieujean, Sophie: No conflict of interest Van Kemseke, Catherine: No conflicts Ellul, Pierre:...................................................................................... Conti, Kelly: No conflict of interest Duricova, Dana: Personal Fees: Lecture fee from Janssen, Takeda, Pfizer, Eli Lilly, AbbVie, Ferring. Horutova, Jana: No conflict of interest Rodríguez-Lago, Iago: Financial support for traveling and educational activities from or has served as an advisory board member for Abbvie, Adacyte, Alfasigma, Biogen, Chiesi, Faes Farma, Ferring, Fresenius Kabi, Galapagos, Johnson & Johnson, Eli Lilly, Mirum Pharmaceuticals, Merck, Pfizer, Roche, Takeda, and Tillotts Pharma. Research support from AbbVie. Supported by a research grant from Gobierno Vasco-Eusko Jaurlaritza (Grant No 2020111061 and 2023222006). Elorza, Ainara: No conflict of interest Ordás Jiménez, Ingrid: I have received financial support for travel and educational activities, and have served as a speaker or advisory board member for the following companies AbbVie, MSD, Pfizer, Takeda, Janssen, Kern Pharma, Chiesi, Falk Pharma, and Faes Farma. I have also received research funding from AbbVie, Faes Farma, and Takeda. Fernandez Clotet, Agnes: None Sebastian, Shaji: No conflict of interest Thut, Jessica: No conflict of interest Mocanu, Irina: No conflict of interest Hernández Ramirez, Vicente: Vicent Hernandez has served as consultant, has served as speaker, has received travel support or research funding from MSD, AbbVie, Ferring, Dr. Falk Pharma, Tillotts Pharma, Pfizer, Takeda, Janssen, KernPharma Biologics, Adacyte, Sandoz, FAES Farma, Galapagos, Lilly and Casen-Recordati Fumery, Mathurin: Grant: Pfizer Personal Fees: Abbvie, Janssen, Takeda, MSD, Biogen, Amgen, Sandoz, Fresenius, Gilead, Celgene, Galapagos, Mylan, Tillots, Ferring, Pfizer, Hospira, CTMA, Boehringer, Lilly, Arena Non-financial Support: Abbvie, Janssen, Takeda, MSD, Galapagos, Ferring, Pfizer Nachury, Maria: Abbvie, Alfa Sigma, Biosynex, Celltrion, Galapagos, Janssen, Lilly, MSD, Pfizer, Takeda Pedersen, Natalia: No any Conceição, Daniel: No conflict of interest Goldiș, Adrian Eugen: No conflict of interest Guedes, Ana: No conflict of interest Ribeiro, Raquel: No conflict of interest Ungaro, Ryan: Personal Fees: AbbVie, Bristol Myers Squibb, Genentech, Lilly, Pfizer, Janssen, Takeda Bigot, Noémie: No conflict of interest Mary, Jean-Yves: No conflict of interest Lambert, Jérôme: No conflict of interest Colombel, Jean-Frédéric: Grant: AbbVie, Janssen Pharmaceuticals, Takeda, Prometheus and Bristol Myers Squibb Lectures from: AbbVie, Roche and Takeda Other: AbbVie, Amgen, AnaptysBio, Allergan, Apini, Arena Pharmaceuticals, Astellas, Boehringer Ingelheim, Bristol Myers Squibb, candidrx Celgene, Celltrion, Clearview Curogen, Eli Lilly, Envision Pharma Ferring Pharmaceuticals, Galmed Research, Glaxo Smith Kline, Roche, Janssen Pharmaceuticals, Kaleido Biosciences, Immunic, Iterative Scopes, Landos, Microba Life Science, Merck, Mirador, Novartis, Otsuka Pharmaceutical, Owkin, Pfizer, Protagonist Therapeutics, Sanofi, Sun Pharma, Takeda, Teva, TiGenix, and is holding stock options in Intestinal Biotech Development Tinoco da Silva Torres, Joana: Grant: Abbvie, Janssen Personal Fees: Pfizer, Janssen, Abbvie, Sandoz, Lilly, Sanofi, Takeda Non-financial Support: Janssen, Abbvie